BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCOLADE HIP STEM

    MDR report key: 916278 · Received September 19, 2007

    Report

    Report Number
    9616680-2007-00125
    Event Type
    Injury
    Date Received
    September 19, 2007
    Date of Event
    August 22, 2007
    Report Date
    August 23, 2007
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    KWY
    PMA / PMN Number
    K994366
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NA

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAD A PROSTHESIS AND FELL. HE HAD A BROKEN FEMUR AND THE STEM WAS REMOVED. A LONG STEM WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCOLADE HIP STEM IMPLANT KWY STRYKER ORTHOPAEDICS CORK NA 10551201

    Patients

    Seq Age Sex Outcome Treatment
    1 NI YR Required Intervention